BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS POLY TIBIAL BUSHING

    MDR report key: 9709907 · Received February 13, 2020

    Report

    Report Number
    0001825034-2020-00687
    Event Type
    Injury
    Date Received
    February 13, 2020
    Date of Event
    December 12, 2019
    Report Date
    February 12, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K002757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 150410 822780 OSS TIBIAL POLY BEARING 12MM, 150476 047810 OSS POLY TIBIAL BUSHING, 150478 850550 OSS POLY LOCK PIN, 150356 449990 OSS 7CM SEG ELLIPT FEMORAL RT, 150477 610600 OSS POLY FEMORAL BUSHINGS 2PK, 150480 527570 OSS AXLE, 150443 719450 OSS MOD PROX TIB 9CM M, 150448 146530 OSS POR STRAIGHT STEM 10.5X150, 150393 852780 OSS POROUS IM STEM 14.5 X 150. REPORT SOURCE: (B)(6). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL EXAMINATION OF THE RETURNED PRODUCTS IDENTIFIED THAT THE TIBIAL BEARING FRACTURED INTO MULTIPLE PIECES (2 LARGE PIECES, OTHER SMALL PIECES, NOT ALL RETURNED) AND THE TIBIAL BUSHING IS FRACTURED (NOT ALL PIECES RETURNED). RETURNED PRODUCTS WERE SUBMITTED FOR FURTHER ANALYSIS. ANALYSIS DETERMINED THAT THE TIBIAL BEARING IS FRACTURED AND HAS SIGNS OF WEAR. THE WEAR WAS CAUSED BY RUBBING/GRINDING AGAINST THE TIBIAL PLATE, POSSIBLY DUE TO OVERLOADING WHILE IN FULL EXTENSION OR HYPEREXTENSION. THE FRACTURE WAS POTENTIALLY CAUSED BY GRADUAL PENETRATION OF THE YOKE INTO THE BEARING MATERIAL DUE TO PULLING FORCES IN EXTENSION FOLLOWED BY SUBSEQUENT FRACTURE DUE TO POTENTIAL OVERLOADING OF THE REDUCED BEARING MATERIAL AND POSSIBLY EXACERBATED BY RELATIVE MOTION OF THE IMPLANT COMPONENTS AFTER THE YOKE PENETRATION. THE TIBIAL BUSHING IS FRACTURED/ CRACKED POSSIBLY DUE TO ASYMMETRICAL OVERLOADING. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THAT THE LOCK PIN IS FRACTURED, WITH ONLY ONE PIECES PHOTOGRAPHED. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED HYPEREXTENSION OF THE RIGHT KNEE, WITH SOFT TISSUE SWELLING AND JOINT EFFUSION. BONE QUALITY APPEARS MILDLY OSTEOPENIC. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2020 - 00688. 0001825034-2019-05260.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY FOUR YEARS POST IMPLANTATION DUE TO HYPEREXTENSION WITH HARD METAL STOP OF THE PROSTHESIS, DUE TO POSSIBLE MALFUNCTION OF THE COUPLING MECHANISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172559 OSS POLY TIBIAL BUSHING PROSTHESIS, KNEE JDI ZIMMER BIOMET, INC. N/A 047810

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization| R